April 17, 2005

Zyprexa Upheld, Generics Stopped

The U.S. District Court for the Southern District of Indiana today upheld Eli Lilly and Company’s 2011 patent on Zyprexa(R), a commonly-used medicine for the treatment of schizophrenia and bipolar disorder. In the case of Eli Lilly and Company v. Zenith Goldline Pharmaceuticals et al., the court ruled in favor of Lilly on all accounts, including the patent doctrines of obviousness, double patenting, inequitable conduct, novelty, and public use.

The generic medications manufacturer based in India; Dr Reddy's Laboratories responded to the announcement in a press release and said "We are disappointed by the court decision and will appeal this decision to the Federal Circuit. Despite today's adverse ruling, our strategy remains unchanged and we continue to make consistent progress towards building a sustainable generics business in the US." The case is now headed to the US Court of Appeals for the Federal Circuit located in Washington that specialises in the US patent law.

Dr Reddy's was one of three generic drug makers who contested the patent on Zyprexa. The other two were Ivax Corporation and the Israel-based Teva Pharmaceuticals.

The companies challenging the Zyprexa patent argued that Olanzapine was covered by a patent that expired in 1995, the year before Zyprexa was first prescribed. The generic drug makers also asserted that Eli Lilly was only able to extend its patent monopoly by misleading the patent office with a flawed clinical study on beagles.

Refuting them, Eli Lilly submitted to the court that the patent was properly issued since Olanzapine had unexpected properties, which were not covered by the first patent. Further, the drug major argued that the drug's commercial success and its use by millions of patients was an indication that other companies would have marketed the drug had they known of those characteristics.

Another recent news article from the Financial Times noted that "Though Eli Lilly recorded a slow growth in Zyprexa sales, the drug had global sales of $ 4.42 billion during last year, which accounted for about one third of Eli Lilly's total business."